The invention relates to the production of harvested plant material in a genetically contained growth environment. More specifically there is disclosed a method for the just-in-time production of harvested plant material, or plant compounds recovered or obtained from harvested plant material.
The advent of just-in-time manufacturing, procurement and purchasing has reached through many corners of the current market. In accordance with this type of business model, increased business efficiency is realized, which corresponds to a significant economic benefit. Companies or individuals who utilize this methodology are no longer required to hold large inventories of produced materials for long periods of time in order to guarantee timely delivery, since they are able to produce the required products in a predictable amount of time.
One area of the economy in which just-in-time manufacture and delivery of products, intermediates, or inputs is that of the nutraceutical or pharmaceutical industries and their inclusion of various plant compounds in products to be produced. The pharmaceutical and nutraceutical industries currently use many different types of plant compounds in different products that they produce, and it would be beneficial if they could practice the same type of scheduled delivery or just-in-time inventory provisioning as has become the norm in, for example, the auto manufacturing industry or any number of other manufacturing areas. The plant compounds used by these nutraceutical or pharmaceutical companies could be any one of any quantity of different types of compounds or constituents recovered in different ways from harvested plant material. Plant made pharmaceuticals (PMPs) is one area in which the problem of delivery scheduling could be addressed, and plants can even be used effectively as a production systems for various monoclonal antibodies or the like—again the ability to conduct scheduled production of the plant material required from which such antibodies can be recovered would be a major advantage over the current state of the PMP and pharmaceutical industries.
One of the problems to date in terms of being able to practice any type of a tight inventory or purchasing provisioning scheme with respect to these products has been the variance of the actual growth and harvest of the plant material, known as the plant platform, which is required to product the various compounds. There is simply not sufficient predictability in the field growth of crops, for example, to be able to guarantee a time when a certain quantity of a harvested crop material of a certain type will be available. Nor is there a guarantee that the harvested crop material of the said certain type, will be of sufficient quality, as the yield of the pharmaceutical/nutraceutical extracts produced within the plant platform is a function of the growth environment. For example, if a crop is being grown in a field and a number of weeks of dark or cold weather occur during the growth period of the plant platforms, the harvesting of the crop will not only be delayed by a significant time, in the worst case scenario, the yield and quality of the produced plant extract will be lower than predicted. As such the grower of the crop, in addition to being late on delivery, will also be unable to deliver a sufficient yield of product of a sufficient quantity or quality to meet the requirements of the customer. If there was a way to produce the necessary crop material and remove the vagaries of weather conditions from the equation, this could assist in the optimization and production of harvested plant material for use in the creation of plant compounds.
A second issue in the growth or production of plant material for use in PMP or nutraceutical applications products is that the plant material must be produced in a genetically pure environment, i.e. it is desirable to be able to the greatest extent possible to limit or eliminate the amount if any of genetic material entering the growth chamber from the outside world. The need to avoid contamination of the growing area with outside genetic material is another area in which significant enhancements or improvements need to be made in order to secure the production of non-contaminated plant material, which has not been exposed to any such foreign matter during its growth cycle. As well environmental concerns dictate that genetic material within the growth chamber must be contained or be isolated from the natural world, as these plant platforms are often genetically modified, and are unfit for animal or human consumption.
One approach currently practiced that partially addresses some of these identified problems, is the growth and harvesting of plant platforms bearing the required plant material in a greenhouse. However, even a greenhouse has limitations in its utility in this role. Economically speaking, greenhouses are expensive to operate, especially when considering costs due to heating/cooling and lighting, particularly in climates that have dramatic seasonal ranges of ambient temperature and sunlight. It is well known that there is some control of the growing conditions inside of the greenhouse, i.e. temperature, light and relative humidity are typically controlled finitely through the use of heating ventilation air conditioning (HVAC) units, sodium vapor lights, and humidifiers/dehumidifiers, respectively. However, the said control of the growing conditions is not perfect, as the HVAC and lighting equipment are incapable to infinitely handle large variances of temperature, light and relative humidity associated with the outdoor environment and climate. There also remains significant possibility of genetic contamination of the growing environment in an above-ground greenhouse environment from the outdoor environment, and vice versa.
The genetic containment of the production of plant-made therapeutics such as pharmaceutical or nutriceutical compounds either grown or expressed in or otherwise refined from harvested plant material is essential, both in terms of isolating the plant material during its growth to ensure no exposure to contaminants, and also in terms of isolating such plant-made compounds from spreading to or contaminating the environment as a whole. The spreading and/or cross propagation of a particular variety of genetically modified plant platform or crop which is beneficial for use as a pharmaceutical expression platform may be of no general environmental value and more importantly may in fact be harmful to the general environment and may not be fit for human or animal consumption or exposure. There is limited genetic containment in a greenhouse environment; however, there is a high risk that genetic containment will not be maintained for a number of reasons.
The first of these reasons is that greenhouses are susceptible to structural damage caused by storms, winds and acts of nature. Any breach of the greenhouse's structure caused by such an event, may result in a genetic outbreak of the genetically modified plant platform. Another reason for genetic cross-contamination is due to the possibility of escape of pollen-laden greenhouse air, through cracks or leaks in the structure or HVAC equipment. The final reason discussed here, is that of bio-terrorism and/or attempted theft of intellectual property. Greenhouses are an easy mark for both bio-terrorist groups that target producers of genetically modified organisms because of fanatical opposition to genetically modified plant platforms, and other parties who may wish to steal a specific type of plant platform for profit. From a business perspective, genetic containment is essential to reduction of liability associated with a breakout. From the just-in-time production viewpoint, and more pertinent to the claimed invention, genetic containment is essential to ensure the quality of the yield of the therapeutic compounds from the plant in order to make just-in-time delivery possible.
Those familiar with the related art will be aware of the benefits of a genetically isolated growth chamber such an underground growth chamber. The benefits are insofar that not only is genetic containment assured, but the possibility of act of corporate espionage, where either plants or processing methods are concerned, or even the possibility of acts of bio-terrorism in certain circumstances are greatly reduced or negated.
What has not been done to date is the “just in time” or scheduled production and delivery of harvested plant material or therapeutic plant compounds, in light of the limitations of plant platforms grown in fields, greenhouses or the like. It would be of significant benefit to industries including the pharmaceutical and nutraceutical industries if it were possible to come up with a method by which plant material and/or compounds therefrom could be scheduled for completion and delivered on a precise and exacting basis in which the forecasted and timely availability of various plant materials would lead to improved efficiency of their business models. The ability to conduct such plant production in a genetically contained growth chamber, which would minimize the possibility of contamination of the harvested plant material is only another desirable benefit but is also essential to the just-in-time production and delivery of plant material for use in the plant-made pharmaceutical and nutraceutical industries.